Clinical trials: Permanent Pacemaker Implantation
Pacemaker DDD, Cardiopulmonary Endurance
Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation…
- Trial name
- NCT04957771
- Testing
- Supervise and guide regular exercise
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Peking University Third Hospital
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Symptomatic Aortic Valve Stenosis
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study.
- Trial name
- NCT01801098
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Cardioneuroablation, Permanent Pacemaker Implantation
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
Different studies for cardiac ganglionated plexus（GP） ablation to treat vagal vascular syncope, sinus node dysfunction, and functional atrioventricular block have been published.
- Conditions
- Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome, Ganglionated Plexus
- Trial name
- GAPS (NCT04149886)
- Testing
- cardiac ganglion plexus ablation(cardioneuroablation), Permanent pacemaker implantation
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
Bilateral Vocal Cord Paralysis
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
The goal of this clinical investigation is to learn about the use of a novel medical device, the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis (BVFP).
- Trial name
- NCT06007170
- Testing
- SPIRION Laryngeal Pacemaker System Implantation and follow-up
- Where
- 6 sites in Austria, Germany
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Aortic Valve Stenosis, AV Block
Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry
There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI Prospective, multicenter, European registry in…
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct-pro (NCT03715894)
- Testing
- transcatheter valve implantation
- Where
- 5 sites in Germany, Netherlands and 1 more
- Volunteers
- 300 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
Bilateral Vocal Cord Paralysis
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement
The goal of this clinical investigation is to learn about the use of a novel medical device, the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis (BVFP) and who have had at least one related…
- Trial name
- NCT06007144
- Testing
- SPIRION Laryngeal Pacemaker System Implantation and follow-up
- Where
- 6 sites in Austria, Germany
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
Arrhythmia
Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation
Permanent pacemaker implantation is traditionally performed under fluoroscopic (X-ray) guidance. Although effective, fluoroscopy exposes patients and medical staff to ionizing radiation.
- Trial name
- RADIANCE (NCT07458724)
- Testing
- Permanent Pacemaker Implantation
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Atrial Fibrillation, Congestive Heart Failure
His Bundle Recording From Subclavian Vein
His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet…
- Trial name
- NCT04115735
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- TriHealth Inc.
Pacemaker Implantation, Pain
Effect of Local Anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) Cream and Reduction in Dose, Pain and Intravenous Analgesic During Permanent Pacemaker Implantation
The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.
- Trial name
- NCT02016976
- Testing
- EMLA Analgesic Cream, Dormicum 2.5 mg and Pethidine 25 mg
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Hillel Yaffe Medical Center
Cardiac Pacing, Permanent Pacemaker Implantation
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients…
- Conditions
- Cardiac Pacing, Permanent Pacemaker Implantation, Postoperative Pain
- Trial name
- PACE-PECS (NCT07739407)
- Testing
- Ultrasound-Guided PECS II Block, Standard Local Infiltration Anesthesia
- Volunteers
- 72 people
- Sponsor
- ferdi gülaştı
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Permanent Pacemaker Implantation
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients
This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among…
- Trial name
- NCT03401593
- Testing
- midazolam with fentanyl
- Where
- South Korea
- Volunteers
- 135 people
- Sponsor
- Yonsei University
Aortic Valve Stenosis
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery.
- Trial name
- TAVISTIM (NCT02337140)
- Testing
- Pacemaker SORIN Group KORA DR, transcatheter aortic valve implantation (TAVI)
- Where
- France
- Volunteers
- 165 people
- Sponsor
- University Hospital, Montpellier
TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder
Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder, Aortic Stenosis, Permanent Pacemaker Implantation
- Trial name
- NCT07201363
- Testing
- Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples, Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
- Where
- Croatia
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Clinical Hospital Center Rijeka